Peter R. Paradiso, Ph.D.

1
Influenza Season 2004

• Peter R. Paradiso, Ph.D.
• V.P. Scientific Affairs Research Strategy
• Wyeth Vaccines

February 3, 2004
2
The Dilemma Assessing Demand and Contingency
Planning

• Driving Demand
• Health People 2010 goals
• Recommendations
• Pandemic Preparedness
• Forecasting demand is critical
• Matching supply to goals requires us to take
  risks, weighing expanded goals with previous
  experience
• In 2002, gt 90M doses were produced, over 20
  discarded
• In 2003, lt 90M doses were produced, shortage of
  vaccine

3
Timing of Influenza Vaccination

• As a rule, vaccination campaigns begin in October
  and end in November, regardless of timing of
  supply

Month of peak influenza activity during 26
influenza seasons US 1976-2002
4
Influenza 2004 Season

• In 2004, influenza activity began while
  vaccination was still occurring
• Illness was reported to be severe, particularly
  in children
• Demand for vaccine beyond November
• First real shortage of vaccine
• we were not prepared to vaccinate into the
  epidemic

5
FluMist Public Sector Distribution

• 12/9/03 CDC holds news conference
• Announces epidemic is widespread and vaccine
  supply limited
• CDC look to purchase whatever doses are
  remaining
• 12/12/03 FluMist offered at 20/dose to CDC and
  states
• 75,000 doses distributed
• 1/12/04 FluMist offered free to CDC and states
• 40,000 doses distributed

6
Influenza-Associated Deaths in Children Aged lt18
Years 2003 04 Influenza Season
64
47
Data compiled from CDC updates around 20 with
underlying condition
7
Track Record for Influenza Vaccination

• gt65 of elderly are vaccinated annually
• Is it possible to meet the Healthy Persons 2010
  goal of 90?
• All major high risk groups are targeted
• Significant epidemics still occur annually
• Conclusion
• A New Paradigm is Needed

8
Increasing Vaccine Supply and Impact

• Broadly vaccinate the population, especially
  children
• School vaccination requirements?
• Begin vaccination campaigns as soon as vaccine is
  available and continue vaccinating until the
  epidemic is over
• Introduce new (improved) vaccines
• Stockpile vaccine to meet goals
• Increase number of vaccine suppliers (?)

9
The Current Environment Does Not Support
Innovation

• Introduction of new, innovative vaccines are very
  expensive and the regulatory hurdles very high
• New product requirements higher than existing
  products
• FluMist
• investment gt1B
• Result Conservative label An indication in
  healthy children 5-17 years of age and healthy
  adults 18-49 years of age
• Reticence on the part of physicians, the public
  health community and the government to promote
  use
• FluMist left unsold in the face of an epidemic
• Lack of money and planning
• Major barriers posed by hospitals and clinics
• Little incentive to innovate

10
Conclusions

• New paradigms, including expanded
  recommendations, are needed
• Innovation must be rewarded
• Risk, especially of supply, must be shared